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Juno (JUNO), Kite Pharma (KITE) Fall After Novartis AG (NVS) Dissolves CAR-T Unit



9/1/2016 6:25:01 AM

Juno, Kite Pharma Fall After Novartis AG Dissolves CAR-T Unit September 1, 2016
By Alex Keown, BioSpace.com Breaking News Staff

NEW YORK – Novartis AG (NVS)’s dissolving of its Gene and Cell Therapy Unit sent ripples across the CAR-T company market earlier this week, caused shares of Juno Therapeutics (JUNO) and Kite Pharma (KITE) to drop in trading.

Juno dropped from $31.53 to $29.07 on Wednesday, although the stock is slowly climbing back up. Shares of Juno are currently trading at $29.72 as of 9:41 a.m. Kite dropped from $58.71 per share to $55.65 per share, although it too has climbed back up. As of this morning, shares of Kite Pharma are trading at $58.07. Shares of Novartis also declined following the news, dropping from $79.36 at close on Tuesday to current share value of $78.30.

Some investors may have been worried that Novartis’s decision was a death blow for the promising, but complex CAR-T field and wanted to shift their portfolios around. CAR-T therapy involves reengineering the body’s T cells to attack cancer cells.

David Pinniger, manager of Polar Capital Biotechnology Fund, told Bloomberg that Novartis’s decision to terminate the Gene and Cell Therapy Unit could be a signal the company believes CAR-T therapy has a limited application. “This smacks of someone big, knowledgeable and sophisticated just pulling back,” Pinniger said, according to Bloomberg.
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For its part, Novartis said it was committed to the continued development of CAR-T therapies, but was absorbing the unit’s work into other parts of the company—part of with the company’s integrated development model. Novartis has seen great success in the field, particularly with its investigational leukemia treatment CTL019. In late 2015, the company reported mid-stage trial results that the treatment wiped out the blood cancer in 93 percent of patients. CTL019 is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of children with relapsed/refractory acute lymphoblastic leukemia. The company plans to file with the U.S. Food and Drug Administration and the European Medicines Agency for regulatory approval in 2017.

Juno and Kite told Bloomberg that Novartis’s decision was not a deterrent for their companies. Hans Bishop, chief executive officer of Juno, told Bloomberg that CAR-T data “has never been better.” He added that it was not unusual for larger pharmaceutical companies to struggle with new technological innovations.

That’s something similar to what Karine Kleinhaus, North American vice president of Pluristem Therapeutics (PSTI) told BioSpace in an emailed statement on Wednesday. Kleinhaus said big pharmaceutical companies such as Novartis have a better option to partner with smaller companies focused on therapies like CAR-T because they are more “able to deal effectively with every aspect of the discovery and development of new therapies, including the complex manufacturing needed to produce highly sensitive biologics.

David Chang, Kite’s chief medical officer supported Bishop. He said having a company like Novartis involved in CAR-T brought attention to the technology, but said the field is growing with or without them.

Kite and Juno are certainly moving forward in their research, despite a few bumps along the way, particularly for Juno, which saw the death of three patients during the mid-stage trial of JCARO15, a CAR-T therapy for patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Kite Pharma recently opened its 43,500-square-foot CAR T cell therapy manufacturing facility that is expected to churn out therapeutic products for up to 5,000 patients annually. The new facility will be able to begin producing Kite’s lead CAR T-cell product candidate, KTE-C19, upon regulatory approval. KTE-C19 is currently in a mid-stage study for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL).


Read at BioSpace.com


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